海外植物药的质量标准-对中药标准化的一些启示-赵中振

)))赵中振*,梁之桃,郭平(香港浸会大学中医药学院,香港)[],,:,,,,,[];;;;[]2009-03-05[]*,Te:l(00852)34112424,E-mai:[e-mail]2090,,19948%[1],1,,,,:(pharmacopoeias)(monographs),,5656;,,,,56,1.11.1.156,5620076,5,20081,3656211[2]561.1.256(BritishPharmacopoeiaCommission),,56562007(traditionalChinesemedicines),[3],562009,3(herbalandcomplementarymedicines)(herbaldrug),2007(liquoricerootforjseintraditionalChinesemedicines)LiquoriceRootforuseintraditionalherbalmedicines()562009(),,ProcessedAstragalusRootforUseinTraditionalHerbalMedicineProduct[4]56,5:(Liquorice,LiquoriceRoot)(LiquoriceDryExtractforFlavouringPurposes)(LiquoriceLiquidExtract)(Liquo-riceRootforuseinTHM)(ProcessedLiquoriceRootforuseinTHMP):(actionanduses)(storage)1.1.35/6(U.S.Pharmacopoeia/NationalFormu-lary,USP/NF)56(AmericanHerbalPharmaco-poeia,AHP)20075120075/6(USP30/NF25)321,312#2119#341620098Vo.l34,Issue16August,20093,34[5]USP32/NF27(200951),,2006,/:5/6,:;(USPreferencestand-ards),,;:;:;(microbialenumeration);;;;;;;;:USP/NF,3,1.1.456(TheJapanesePharma-copoeia),,,561886,1520064115,2,1483,(crudedrug)200,192,6,2,,[6]561.1.5,15000,2000,(Ayurve-da),,56(TheAyurvedicPharmacopoeiaofIndia),2003,4,326,180,2,3478,10068[7]56:;:;:;:;:;(propertiesandaction):;:;:;1.1.6,,5620053,342276,3747[8]56,,(preliminaryprocessing)(processing),,,,(clarity)(uniform-ity)(relativedensity);,(smoothness)1.1.720066562004,,,56,200,200[9]56,,;,,;(),;(),,;,,,1.1.856(/0)56,2003,3,61,33(),28[10]436200910,100,200#2120#341620098Vo.l34,Issue16August,20097,,,,,(),,,,,,,,56,,,,,1.21.2.1WHO19991[11],20032007,23,30,31[11]428,WHO2(definition):;(synonyms):;(selectedvernacularnames):;:,;:;(plantmaterialofinterest):(generalappearance)(organolepticproperties);:;:(radioactiveresidues);:;:;(me-dicinaluses):(usessupportedbyclinicaldata)(usesdescribedinpharmacopoeiasandwellestablisheddocuments)(usesdescribedintraditionalmedicine);:(experimentalpharmacology)(clinicalpharmacology)(toxicology);;;(warnings);:;1.2.21978E,E,,56380,360,(singleherbs)186,(fixedcombinations)66,(componentcharacteristics)2,110,6,10(AmericanBotanicalCouncil),1998[12],,,,56,200056,107,[13]56,:(pharmacokinetics)(pharmacologicalprop-erties,pharmacokinetics,toxicology)(combinationpartnerinherbcombinations),56,1989(ESCOP)80,,[14]1.2.31974,1983,1990,1996199656(ScientificCom-mitteeofBritishHerbalMedicineAssociation)199084,85,169[15]56,565656:,,;(characteris-tics):,;:;:;(ma-terialofcommerce):;:,,;:,,,,,1.2.41995,#2121#341620098Vo.l34,Issue16August,2009300,([16])([16])([16]),561956:()();:;:3,;:;:,;:,,,,();:;:;:,,,,,4[17]:1,;2,,2a,,2b,,2c,,2d,;3,/0,;4,1.2.51000,556(TheKoreanHerbalPharmacopoeia,KHP)1984,1985,1987232002,56,56,384[18]562,,569,:1.2.656(IndianHerbalPharma-copoeia,IHP)(IndianDrugmanu-facturers'Association)IHP2,40,2002,52[19]56,,,,,,1.3,,,,(1)5656,,,56,56565656,(1)56565/656,565625/656,56565/65656,2,,,,,,,,[20],(Cr),(Cr)(2),#2122#341620098Vo.l34,Issue16August,2009,56,1/TLCHPLCKKKK7K77KK7KKKKKKKKKKK+1)++7KKKKKKKKKKK++K7KKKKKKKKKK7K77K7KKKK72)KKK7KKKKKKKKKKKK66K6KKK+KKKKKKKKKKKK7KKKKKKKKK+KK6KKK+++7KKKK771)K77K7:+.;6.;7.;K.;1);2)5/62@10-6(2005)(NSF/ANSI173-2006)(2005)(2002)(KFDA/2005-62)(As)210210510510510(Cd)013013013013013(Pb)51051010101010510310(Hg)012012012012(Cu)2010(Cr)210,3(3,4),,,,,,,,,,,20,,,,,,,,,,#2123#341620098Vo.l34,Issue16August,200934(CP2005,JP14,KP2002,VP2005)/cm/cm/cm/cmFoeniculumvulgareCPFructusFoeniculi014~0180115~0125---KJPFoeniculiFructus0135~018-011~0125-KKKPFoeniculiFructus013~018-011~013--KVPFructusFoeniculi0180115~0125--KKGardeniajasminoidesCPFructusGardeniae115~3151~115--KJPGardeniaeFructus1~5-1~115-K-KPGardeniaeFructus1~5-1~115-K-VPFructusGardeniae2~4151~2--KKPaeoniasuffruticosaCPCortexMoutan5~20015~112-011~014KJPMoutanCortex5~8018~115-015K-KPMoutanCortexRadicis5~8018~115-015--VPCortexPaeoniaesuffruticosae5~20015~112-011~014K-PanaxginsengCPRadixetRhizomaGinseng3~151~2--KKJPGinsengRadix5~20015~3--K-KPGinsengRadixAlba12~201~3--K-VPRadixGinseng3~151~2--KKZingiberofficinaleCPRhizomaZingiberisRecens4~18--1~3--JPZingiberisRhizoma2~41~2--K-KPZingiberisRhizoma2~41~2--K-VPRhizomaZingiberis3~7--015~115KK:CP1;JP1;KP1;VP1;K1(4)44(CP2005,JP14,KP2002,VP2005)%AstragalusmembranaceusCPRadixAstragaliTLCBHC-[510DDTPCNB)JPAstragaliRadi-[1310[510KPAstragaliRadi-[1310[510VPRadixAstragaliMembranaceiTLC-[1210[510BupleurumscorzonerifoliumCPRadixBupleuriTLC--[810JPBupleuriRadixTLC-[615KPBupleuriRadixTLC-[615VPRadixBupleuriTLC[1210[810PanaxginsengCPRadixetRhizomaGinsengTLC-[1210[510JPGinsengRadixTLCBHCDDT-[412KPGinsengRadixAlbaTLC-[412VPRadixGinsengTLC---AstragalusmembranaceusCPRadixAstragali[110\1710()\0104(TLC)JPAstragaliRadi[110--KPAstragaliRadi[110--VPRadixAstragaliMembranacei---BupleurumscorzonerifoliumCPRadixBupleuri-\1110()-JPBupleuriRadix[215\1110()-KPBupleuriRadix[215-a\013(HPLC)VPRadixBupleuri-\1110()-PanaxginsengCPRadixetRhizomaGinseng[110-Rg1+Re\013%(HPLC)\012(HPLC)JPGinsengRadix-\1410()-KPGinsengRadixAlba-\1410()-VPRadixGinseng---#2124#341620098Vo.l34,Issue16August,2009,,